OBJECTIVE: To evaluate the safety and efficacy of the Infinnium© stent (A Paclitaxel coronary stent system from India) in patients from daily practice.

METHODS: The study was designed as open label, non-randomized, multi-center study. The study included 109 non-randomized patients, with a total 176 Infinnium© stents implanted (1.64 Infinnium© / patient).
    The first Infinnium Paclitaxel DES deployed in Saudi Arabia was on the 25th of July 2004. Until the 15th of September 2005, 176 stents were deployed in 109 patients. The procedure was successful in 173/176 stents (98.3%). 
    The patients included 84 males (77%) and 25 females (33%), with a mean age of 57 ± 11 yrs (32-85 yrs). Mean CCS anginal Class was 3 (±1) with U.A.P in 44 cases, 7 with NSTEMI, and 11 with STEMI, 2 in cardiogenic shock.
The patients had the following risk factors for coronary artery disease: smoking in 40/109 (37%), Diabetes in 57/109 (52%), hypertension 69/109 (63%), and hyperlipidemia in 75/109 (69%). 82/176 (46.6%) stents were deployed in LAD and diagonals, 31 (17.6%) in Circumflex and OM, 3 (1.8%) in Intermediate, 59 in RCA (33.5%), and 1 in LMCA.
    Mean RVD was 2.92 ± 0.4 (2.5 - 4mm), and mean lesion length was 18.2 ±7 (6-35mm). 75/176 (42%) stents were deployed in small vessels (less than 2.6mm), and 94/176 (53%) for long lesions (more than 25mm). 38/176(21.6%) lesions were calcified, and 24(13.6%) were restenotic.


RESULTS: All stents except two were deployed successfully (98.4%) with acute stent thrombosis occurring in 2 patients, both of whom had sub-therapeutic anticoagulation (ACT less than 150 sec). One of these 2 patients died. (He had preoperative LVEF less than 20%, 3-vessel CAD, denied surgery, and was hemodynamically unstable).
      All patients were followed up clinically at 1, 3, 6, and 12 months by clinic visit or over the phone. Symptomatic patients underwent coronary angiography. 
There were 3 late thromboses (after 2 months), with two sudden deaths in the 1st year of follow-up, one of which is in a patient with LVEF of 25%. Two of the above stents were not fully expanded for different reasons on review of the initial intervention angiogram.

CONCLUSION: The stents were easily deployed despite the complexity of the lesions treated, which represent real world day-to-day cases, rather than selected ideal lesions. There was a high prevalence of Diabetes, small vessels, and long lesions in the treated cases compared to randomized trials.
     To assess the long-term efficacy, larger number of patients with worldwide registry with long term follow up is required.